Quality Unit Business Process Specialist

GSK•Marietta, PA

38d•Onsite

About The Position

The Quality Unit Business Process Specialist is responsible for quality oversight of SAP processes, business rules, and systems used and the inter-relatedness between each process, rule, or system in order to identify opportunities for improvement and to avoid conflict between processes and systems. As a member of the Quality Assurance Operations, this position is co-responsible for the site and the department results. You will act as a Quality Unit Business Process Specialist supporting a United States manufacturing site. You will partner day-to-day with operations, engineering, IT and quality teams to design, implement and sustain quality processes that keep production compliant and reliable. You will help translate business needs into clear, documented processes and support continuous improvement. We value people who are practical, curious, and ready to coach others. This role offers visible impact, learning and growth aligned with our mission of uniting science, technology and talent to get ahead of disease together.

Requirements

Bachelor’s degree in life sciences, engineering, quality, or a related technical field.
3-5 years’ experience in cGMP production or quality control for cGMP manufacturing.
1-3 years’ experience designing or implementing business processes or SAP systems.
Experience t he implementation and changes must be performed under cGMP change control.
Expert knowledge cGMP quality systems and at intermediate knowledge of SAP or business processes ensures that candidates possess the skills to perform quickly in this position.
Practical experience writing or maintaining procedures, work instructions, or process documentation.
Experience with Good Manufacturing Practices and Good Documentation Practices.
Experience participating in change control, CAPA, or deviation investigations.
Strong verbal and written communication skills and ability to work on-site with cross-functional teams.

Nice To Haves

Experience in biologics or pharmaceutical manufacturing environments with computerized systems or digital manufacturing tools such as MES, LIMS or Green belt certification.
Experience with risk assessment tools and verification of mitigation actions.
Training or experience in structured root cause analysis methods such as DMAIC or similar.
Proven ability to influence and coach colleagues across functions and levels.
Experience monitoring and reporting quality KPIs and using data to drive improvements.

Responsibilities

Act as the Quality Assurance oversight to Production SAP use, business rules, outcomes and compliance including creation of new material master data.
QA Oversight for Serialization Line client recipe creation and modification.
Key contact for internal departments and other sites for information and assessment and distribution regarding master data.
Act as site Quality Consultant for SAP when issues arise.
Provide input to global procedural revisions in order to ensure site Master Data needs are being addressed to improve standing with GQA.
Act as Quality Assurance oversight of QC Master Data, ensuring adherence to procedures, policies, standards and FDA regulations.
Demonstrated familiarity and compliance with cGMPs, EHS procedures and regulations, facility regulatory guidelines and standard operating procedures.
Be SME for local SOPs where SAP is utilized as well as QA approver / compliance authority for QC SOPs relating to QC master data, ensuring.
No conflict between site processes, compliance with CFR requirements and GSK higher level documents, consistent use of SAP across departments, consistency/ clarity between all relevant processes, ease of use for local departments, opportunities for improvement are identified and implemented and clear traceability, visibility and accuracy of decision-making processes
Train users related to SAP business processes
Assist with QA Systems objects (including deviations, change controls and CAPA involving SAP use.
Lead the design, documentation and maintenance of quality unit business processes and standard operating procedures.
Work with cross-functional teams to translate operational and technical requirements into practical process controls.
Support change control, risk assessments and quality impact evaluations for process and system changes.
Contribute to investigations, root cause analysis and corrective and preventive actions to prevent recurrence.
Monitor quality metrics and trends and recommend process improvements to reduce risk and improve performance.